Joint Microbiome Study for the Knee

NCT ID: NCT05254145

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2023-02-28

Brief Summary

Prosthetic joint infection (PJI) is a devastating complication following arthroplasty. An utmost effort has been done to clarify risk factors and microbiology of PJI. We now know the most frequent infecting microorganisms are members of the skin microbiome. These microorganisms are thought to get into the joint and infect the prosthesis during the peri-operative and/or post-operative period. Nevertheless, recent studies have suggested, bacteria may be present in the joint even before the first incision, suggesting the existence of a joint microbiome. Therefore, we aimed to determine the bacterial composition from different knee conditions.

Conditions

Knee Osteoarthritis; PJI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

This group will include participants without an arthritic knee. These participants will be recruited from the Orthopedic Sports Medicine consultation

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.

Group B

This group will include participants undergoing primary knee arthroplasty (KA).

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.

Group C

This group will include participants undergoing a surgical procedure whose opposite knee has no history of arthritis

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.

Group D

This group will include participants undergoing knee revision surgery with no suspicion of infection (aseptic knee revision replacement)

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.

Group E

This group will include participants undergoing knee revision with a known infection (septic knee revision replacements)

Next Generation Sequencing

Intervention Type: DIAGNOSTIC_TEST

During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.

Interventions

Next Generation Sequencing

During the participants surgical procedure, a total of 3 ml of synovial fluid (joint fluid collected from the knee) will be collected per joint. Upon collection, the samples will be deidentified, stored on ice and shipped with a study ID number to MicroGenDx for Next Generation Sequencing.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• All patients 18 years or older who give verbal and written informed consent for the retrieval of experimental samples and data collection.
• Group A: Subjects with lack of Osteoarthritis (OA) evidence, invasive examinations, minor procedures, cartilage damage, and/or synovitis in joints.
• Group B: Patients undergoing primary knee arthroplasty (partial or total).
• Group C: Contralateral non-affected (native) joint without knee arthroplasty, history of septic arthritis (SA), invasive examinations and/or minor procedures.
• Group D: Patients undergoing aseptic knee revision surgery.
• Group E: Patients undergoing septic knee revision surgery

Exclusion Criteria

• Withdrawal of informed consent, suspicion of PJI, surgical site infection (SSI) or septic arthritis (SA) before samples retrieval, use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis), inflammatory arthritis, systemic rheumatic disorder, high risk of infection.
• Group A: History and/or suspicion before/at samples retrieval of SA in native joint.
• Group B: History and/or suspicion before/at samples retrieval of SSI or SA in the affected joint.
• Group C: No additional criterion.
• Group D: History and/or suspicion before/at samples retrieval of PJI, SSI, SA in the affected joint
• Group E: No additional criterion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JPAR22D.042

Identifier Type: -

Identifier Source: org_study_id